UMIN-CTR Clinical Trial

Basic information
Public title	Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochloride
Acronym	The DUET study
Scientific Title	Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochloride
Scientific Title:Acronym	The DUET study
Region	Japan

Condition
Condition	Secondary hyperparathyroidism
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ratio of achievement of more than 50% reduction and under 240pg/dl in intact parathyroid hormone (iPTH) after 12 weeks of treatment
Key secondary outcomes	-Ratio of achievement of 60<=iPTH<=240 after 12 weeks of treatment -Ratio of achievement of more than 30% reduction in iPTH after 12 weeks of treatment -Ratio of achievement of more than 30% reduction and 60<=iPTH<=240 after 12 weeks of treatment -Ratio of achievement of more than 50% reduction in iPTH after 12 weeks of treatment -Change in iPTH after 2, 4, 6, 8, 10 and 12 weeks of treatment relative to the baseline -Change in CalciProtein Particle (CPP) and Fibroblast Growth Factor 23 (FGF23) after 6 and 12 weeks of treatment relative to the baseline among treatment groups -Change in Ca, P, CaXP and Mg after2, 4, 6, 8, 10 and 12 weeks relative to the baseline among treatment groups -Change in Bone Specific Alkaline Phosphatase (BAP) and Tartrate-resistant Acid Phosphatase 5b (TRACP5b) after one year of treatment relative to the baseline among treatment groups -Comparison of aortic calcification before and after observation -Ca, P and iPTH levels after one year of treatment -Comparison of normalized ratio of hypocalcemia between VitD and calcium preparations -Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Etelcalcetide+active Vitamin D for 12weeks
Interventions/Control_2	Etelcalcetide+oral calcium (calcium carbonate) for 12weeks
Interventions/Control_3	Control [active Vitamin D + oral calcium (calcium carbonate)] for 12weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1.patients on maintenance hemodialysis 3 times a week 2.patients with more than one-year hemodialysis vintage 3.patients who are judged stable 4.older than 20 years and younger than 100 years 5.iPTH >=240 pg/ml within 4 months 6.corrected Ca >=8.4mg/dl at enrollment 7.patients who are able to write informed consent
Key exclusion criteria	1.patients who have been prescribed etelcalcetide before 2.bisphosphonate users within 24 weeks 3.primary hyperparathyroidism 4.undergoing parathyroidectomy or intervention therapy to parathyroid within 90 days before enrollment 5.scheduled parathyroidectomy, intervention therapy to parathyroid or kidney plantation 6. pregnant or breast feeding 7. patients who are deemed unsuitable by a physician, for instance cancer, severe infection and severe complication 8. patients who are prescribed Maxacalcitol, over 10[micro]gx3/week at obtainment of IC 9. patients who are prescribed Calcitriol, over 0.75[micro]gx3/week at obtainment of IC 10. patients who are prescribed other active VitD, over half of maximum dose at obtainment of IC 11. patients who are prescribed precipitated calcium carbonate, over 3g/day at obtainment of IC
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Shoichi Middle name Last name Maruyama
Organization	Nagoya University Graduate School of Medicine, Internal Medicine
Division name	Nephrology
Zip code	4648550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	+81-52-744-2192
Email	marus@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Sawako Middle name Last name Kato
Organization	Nagoya University Graduate School of Medicine, Internal Medicine
Division name	Nephrology
Zip code	4648550
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	+81-52-744-2192
Homepage URL
Email	Kato07@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine, Nephrology
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University
Address	65 Tsurumai Showa Nagoya
Tel	052-741-2111
Email	ethics@med.nagoya-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	120
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 01 Month 01 Day
Date of IRB	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 14 Day
Last modified on	2020 Year 12 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034259

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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